BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEW LIGASURE 5MM

    MDR report key: 4132522 · Received October 1, 2014

    Report

    Report Number
    1717344-2014-00815
    Event Type
    Malfunction
    Date Received
    October 1, 2014
    Date of Event
    August 25, 2014
    Report Date
    September 4, 2014
    Manufacturer
    COVIDIEN LP
    Product Code
    GEI
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ONE USED LF1537 WAS RECEIVED FOR EVALUATION AND VISUAL INSPECTION FOUND NO DEFECTS. THE DEVICE WAS ACTIVATED ON SIMULATED TISSUE WHILE PRESSING THE BUTTON IN VARIOUS LOCATIONS TO DETECT ANY PROBLEMATIC ACTIVATION ISSUES. THE ROTATION KNOB WAS TURNED TO EACH STOP AND ACTIVATED. FUNCTIONAL TESTING WAS ALSO PERFORMED ON PORCINE KIDNEY TISSUE. MULTIPLE SEALS ON VARIOUS SIZE VESSELS WERE MADE. ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY AND END TONES WERE HEARD INDICATING COMPLETED ACTIVATION CYCLES. THE KNIFE CUT OF THE DEVICE WAS TESTED ON A SILICONE TEST STRIP WITH ACCEPTABLE RESULTS. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE DEVICE WAS NOT SEALING PROPERLY. THE SURGEON HAD TO USE STANDARD BIPOLAR FORCEPS TO SEAL THE TISSUE INSTEAD. THERE WAS NO ADVERSE EFFECT TO THE PATIENT. ADDITIONAL QUESTIONS HAVE BEEN ASKED BUT TO DATE NO INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    610527 NEW LIGASURE 5MM LIGASURE VESSEL SEALING SYSTEM GEI COVIDIEN LP LF1537 41490010X

    Patients

    Seq Age Sex Outcome Treatment
    1